Actively Recruiting
COSENSE-1: Feasibility Study of Functional Precision Medicine to Select Oxaliplatin- or Irinotecan-Based Chemotherapy for Metastatic Colorectal Cancer
Led by St. Olavs Hospital · Updated on 2025-05-25
148
Participants Needed
1
Research Sites
665 weeks
Total Duration
On this page
Sponsors
S
St. Olavs Hospital
Lead Sponsor
N
Norwegian University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a functional precision medicine platform to choose between two chemotherapy regimens—oxaliplatin-based and irinotecan-based—for adults aged 18 and older with metastatic colorectal cancer that cannot be cured or removed by surgery. This phase II, single-center, single-arm study focuses on patients with microsatellite stable (MSS) or proficient mismatch repair (pMMR) tumors. The study aims primarily to test the feasibility of using this platform to guide treatment selection and secondarily to assess treatment response, progression-free survival, overall survival, and treatment toxicity. Participants will receive chemotherapy selected based on testing their tumor samples (tumouroids) to see which regimen may work best. The two chemotherapy options evaluated are FOLFOX (oxaliplatin-based) and FOLFIRI (irinotecan-based), both possibly combined with antibodies. Treatment will follow standard dosing guidelines and national recommendations, with chemotherapy planned to start within 28 days after referral. Each participant will be involved for up to 36 months, including treatment lasting up to 6 months, with one study visit during this period. Throughout the study, researchers will collect tumor response data using RECIST v1.1 criteria and monitor survival outcomes and treatment side effects using established grading methods. Tumor samples will be obtained for analysis, and the time from referral to treatment start will be recorded. The study also includes exploratory research to improve the testing platform. Safety and treatment adherence will be closely monitored, and participants will be followed for efficacy and toxicity outcomes for up to several years.
CONDITIONS
Brief Title
Testing a Functional Precision Medicine Approach to Select Chemotherapy for Metastatic Colorectal Cancer (COSENSE-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- ECOG performance status 0 or 1
- Provided informed consent
- Acceptable organ function as defined in the protocol
- Women of child-bearing potential and men must use highly effective contraception
- Histologically confirmed pMMR/MSS adenocarcinoma of colon or rectum
- Unresectable metastatic disease at study entry
- Metastatic or primary lesion available for biopsy
- Measurable or evaluable disease by RECIST 1.1
- Both FOLFOX (+/- antibody) and FOLFIRI (+/- antibody) regimens are equally recommended by a physician
- Eligible for full (100%) chemotherapy doses at first cycle
- Chemotherapy can be scheduled within 28 days from referral
You will not qualify if you...
- Metastatic MMR deficient/MSI adenocarcinoma
- Ineligible for full (100%) chemotherapy doses at first cycle
- Not equally eligible for FOLFOX (+/- antibody) and FOLFIRI (+/- antibody) regimens
- ECOG performance status 2 or worse
- Pregnant or planning pregnancy during the study
- Breastfeeding
- Psychological, geographical, familial, or social conditions preventing study compliance
- Inability to understand or comply with study procedures
- Contraindications listed in the relevant medication information
- Chemotherapy cannot be scheduled within 28 days from referral
- Partial or complete DPD deficiency
- Central nervous system metastasis
- Unresolved toxicities from prior treatments making patient unfit
- Antitumor treatment within 30 days before inclusion (except hormonal therapy)
- Significant cardiovascular disease or recent serious cardiac events
- Clinically significant peripheral sensory neuropathy
- Recent serious thromboembolic events within 6 months
- History or evidence of interstitial pneumonitis or pulmonary fibrosis
- Previous severe allergic reaction to treatment components
- Any disease increasing risks associated with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive oxaliplatin-based or irinotecan-based chemotherapy selected based on a functional precision medicine platform using patient-derived tumouroids.
1 visit per participant
Duration - Up to 48 months
Participants are monitored for tumor response, progression-free survival, overall survival, and toxicity after treatment ends.
1 visit per participant
Trial Site Locations
Total: 1 location
1
St. Olavs Hospital
Trondheim, Norway
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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